输卵管整形与输卵管切除治疗双侧输卵管重度积水不孕女性长期妊娠结局的比较

doi:10.3969/j.issn.1674-8115.2023.06.009

上海交通大学学报（医学版） ›› 2023, Vol. 43 ›› Issue (6): 728-737.doi: 10.3969/j.issn.1674-8115.2023.06.009

输卵管整形与输卵管切除治疗双侧输卵管重度积水不孕女性长期妊娠结局的比较

颜丽(), 汪央, 刘小奕, 潘漪莲, 朱旻蛟, 刘璟蓝(), 张健()

上海交通大学医学院附属国际和平妇幼保健院妇产科，上海市胚胎源性疾病重点实验室，上海 200030

收稿日期:2023-02-03 接受日期:2023-05-08 出版日期:2023-06-28 发布日期:2023-06-28
通讯作者: 刘璟蓝,张健 E-mail:yanli7720@163.com;jianglan.liu@163.com;zhangjian_ipmch@sjtu.edu.cn
作者简介:颜丽（1997—），女，住院医师，学士；电子信箱：yanli7720@163.com。
基金资助:
国家重点研发计划(2018YFC1002102);上海市临床重点专科建设项目(shslczdzk01802)

Comparison of long-term pregnancy outcomes between neosalpingostomy and salpingectomy for infertile women with bilateral severe hydrosalpinx

YAN Li(), WANG Yang, LIU Xiaoyi, PAN Yilian, ZHU Minjiao, LIU Jinglan(), ZHANG Jian()

Department of Obstetrics and Gynaecology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Key Laboratory Embryo Original Diseases, Shanghai 200030, China

Received:2023-02-03 Accepted:2023-05-08 Online:2023-06-28 Published:2023-06-28
Contact: LIU Jinglan,ZHANG Jian E-mail:yanli7720@163.com;jianglan.liu@163.com;zhangjian_ipmch@sjtu.edu.cn
Supported by:
National Key Research and Development Program of China(2018YFC1002102);Shanghai Municipal Key Clinical Specialty Construction Project(shslczdzk01802)

摘要/Abstract

摘要：

目的·比较双侧输卵管重度积水不孕女性接受输卵管整形术和输卵管切除术后的妊娠结局。方法·前瞻性纳入2005年至2012年因双侧输卵管重度积水在上海交通大学医学院附属国际和平妇幼保健院接受手术治疗的20~40岁不孕女性进行队列研究。通过术前医患共同决策制定治疗方案，并将研究对象分为输卵管整形术组与输卵管切除术组。从临床数据库中收集2组人群的临床信息，包括年龄、出生地、生育史、术前子宫输卵管造影结果、术中发现及妊娠结局。术后每年通过门诊复诊或电话问卷随访妊娠结局至2020年7月。采用意向性分析以及符合方案分析比较2组人群的妊娠结局，通过Kaplan-Meier生存分析、COX比例风险模型研究接受不同手术女性的活产结局；同时以年龄35岁为界，对研究人群进行亚组生育结局分析。主要结局指标为活产率、累积活产率及影响活产的因素；次要结局指标包括受孕方式、获得活产的时间、生化妊娠率、临床流产率、异位妊娠率。结果·共纳入113例双侧输卵管重度积水的不孕女性，其中58例接受双侧输卵管整形术，55例接受双侧输卵管切除术。双侧输卵管切除术后的累积活产率高于双侧输卵管整形术（76.36% vs 62.07%，HR=2.18，95%CI 1.37~3.45）。输卵管整形组中，34.48%（20/58）的女性通过辅助生殖治疗获得活产，27.59%（16/58）的女性通过自然受孕获得活产；且自然受孕活产结局主要发生在初次输卵管整形术后的3年内，而输卵管切除组的活产结局均通过辅助生殖治疗获得。输卵管整形组异位妊娠发生率明显高于输卵管切除组（20.69% vs 1.82%，P<0.001），2组生化妊娠率、临床流产率差异无统计学意义。进一步年龄分层分析显示，35岁以下双侧输卵管重度积水女性接受输卵管整形术（51例）者的累积活产率显著低于输卵管切除术（48例）后（HR=2.25，95%CI 1.39~3.66）；35岁及以上女性2组（各7例）累积活产率的差异无统计学意义（HR=1.60，95%CI 0.36~7.19）。此外，在校正年龄、既往流产史、子宫肌瘤、良性卵巢囊肿、子宫内膜异位症等混杂因素后，COX比例风险分析显示，与输卵管整形术相比，输卵管切除术与活产呈正相关（aHR=1.94，95%CI 1.18~3.18）。结论·对于双侧输卵管重度积水的不孕女性，输卵管整形术存在一定自然受孕的可能和异位妊娠的风险，输卵管切除术能带来更高的累积活产率，但需要通过术后辅助生殖治疗。

关键词: 输卵管积水, 输卵管不孕, 输卵管整形术, 输卵管切除术, 活产率

Abstract:

Objective ·To compare the pregnancy outcomes of infertile women with bilateral severe hydrosalpinx receiving neosalpingostomy or salpingectomy. Methods ·The single-center prospective cohort study from 2005 to 2012 focused on pregnancy outcomes of infertile women aged 20?40 years, with bilateral severe hydrosalpinx, undergoing bilateral neosalpingostomy or salpingectomy in International Peace Maternal and Child Health Hospital, Shanghai Jiao Tong University School of Medicine. The choice for treatment was based on a shared decision approach, and the participants were divided into the neosalpingostomy group and salpingectomy group. After registration of baseline characteristics, including age, birth place, reproductive history, preoperative hysterosalpingography results, surgical findings, and pregnancy outcomes, women were followed up on an annual basis until July 2020 for the occurrence of live birth by outpatient follow-up or telephone questionnaire. Intention-to-treat analysis and per-protocol analysis were applied to compare the pregnancy outcomes. Kaplan-Meier analysis and COX proportional hazard model were used to analyze the reproductive outcomes. In addition, subgroup analysis was performed based on age stratification. The main outcome measures were live birth rate, cumulative live birth rate, and factors affecting live birth. Secondary outcome measures included the mode of conception, time to live birth, biochemical pregnancy rate, clinical miscarriage rate, and ectopic pregnancy rate. Results ·A total of 113 women were included in the analysis, 58 women underwent bilateral neosalpingostomy, and 55 women underwent bilateral salpingectomy. The study demonstrated that in infertile women with bilateral severe hydrosalpinx, bilateral salpingectomy achieved higher cumulative live birth rate than bilateral neosalpingostomy (76.36% vs 62.07, HR=2.18,95%CI 1.37?3.45). In the neosalpingostomy group, 34.48% (20/58) live births were obtained after in vitro fertilization treatment, and 27.59% (16/58) live births were obtained through spontaneous conception which mainly occurred within 3 years after initial neosalpingostomy, while all live births in the salpingectomy group were obtained after assisted reproductive therapy. However, the risk of ectopic pregnancy was higher in the neosalpingostomy group than that in the salpingectomy group (20.69% vs 1.82%, P<0.001). No statistically significant differences regarding biochemical pregnancy and clinical miscarriage between the two groups were found. During the subgroup analysis, the cumulative live birth rate of the salpingectomy group (n=51) was significantly higher than that of the neosalpingostomy group (n=48) in women younger than 35 years old (HR=2.25, 95%CI 1.39?3.66), while between two groups of women aged 35 years old or older, there was no statistically significant difference in the cumulative live birth rate (HR=1.60, 95%CI 0.36?7.19). In addition, after adjustment for confounding factors including age, previous abortion history, fibroid, benign ovarian cyst, and endometriosis, COX proportional hazard analysis revealed that salpingectomy was positively correlated to live birth compared with neosalpingostomy (aHR=1.94, 95%CI 1.18?3.18). Conclusion ·For infertile women with bilateral severe hydrosalpinx, neosalpingostomy provides the possibility for spontaneous conception but also brings about certain risk of ectopic pregnancy. Bilateral salpingectomy can achieve higher cumulative live birth rate while receiving postoperative in vitro fertilization treatment.

Key words: hydrosalpinx, tubal subfertility, neosalpingostomy, salpingectomy, live birth rate

中图分类号:

R713.5

颜丽, 汪央, 刘小奕, 潘漪莲, 朱旻蛟, 刘璟蓝, 张健. 输卵管整形与输卵管切除治疗双侧输卵管重度积水不孕女性长期妊娠结局的比较[J]. 上海交通大学学报（医学版）, 2023, 43(6): 728-737.

YAN Li, WANG Yang, LIU Xiaoyi, PAN Yilian, ZHU Minjiao, LIU Jinglan, ZHANG Jian. Comparison of long-term pregnancy outcomes between neosalpingostomy and salpingectomy for infertile women with bilateral severe hydrosalpinx[J]. Journal of Shanghai Jiao Tong University (Medical Science), 2023, 43(6): 728-737.

图/表 6

图1 手术方法图解Note： A. The method of neosalpingostomy. A cross cut was made at the thinnest part of the blind ending fallopian tube, gently extended up to 1.5 cm in order to form 4 fimbrial flaps, and sutured to the serosal layer. B. The method of salpingectomy. The mesosalpinx was cut just below the fallopian tube by using an ultrasonic device in order to prevent injury of the blood supply to the ipsilateral ovary, and the fallopian tube was resected close to the interstitial part.

Fig 1 Methods of the surgery

图2 研究人群入选流程图

Fig 2 Flow chart of study population selection

表1 基线资料与术中发现

Tab 1 Baseline characteristics and surgical findings

Item	Salpingectomy group (n=55)	Salpingostomy group (n=58)	P value
Age/year	30.53±3.73	29.74±3.66	0.293
Birth place/n(%)			0.772
Shanghai	43 (78.18)	44 (75.86)
Outside of Shanghai	12 (21.82)	14 (24.14)
Miscarriage/n(%)			NA
No	2 (3.64)	0 (0)
Yes	53 (96.36)	58 (100.00)
Abortion/n(%)			0.523
No	28 (50.91)	26 (44.83)
Yes	27 (49.09)	32 (55.17)
Polycystic ovarian syndrome/n(%)			0.724
No	53 (96.36)	54 (93.10)
Yes	2 (3.64)	4 (6.90)
Leiomyoma/n(%)			0.676
No	49 (89.09)	53 (91.38)
Yes	6 (10.91)	5 (8.62)
Adenomyoma/n(%)			NA
No	54 (98.18)	58 (100.00)
Yes	1 (1.82)	0 (0)
Endometrial polyp/n(%)			0.815
No	50 (90.91)	52 (89.66)
Yes	5 (9.09)	6 (10.34)
Benign ovarian cyst/n(%)			NA
No	52 (94.55)	58 (100.00)
Yes	3 (5.45)	0 (0)
Mullerian duct cyst/n(%)			NA
No	55 (100.00)	55 (94.83)
Yes	0 (0)	3 (5.17)
Fitz-Hugh-Curtis syndrome/n(%)			1.003
No	53 (96.36)	56 (96.55)
Yes	2 (3.64)	2 (3.45)
Endometriosis/n(%)			0.394
No	53 (96.36)	50 (86.20)
Stage 1‒2	1 (1.82)	4 (6.90)
Stage 3‒4	1 (1.82)	4 (6.90)

表2 输卵管整形组与输卵管切除组术后生育结局的比较

Tab 2 Comparison of pregnancy outcomes between the neosalpingostomy group and salpingectomy group

Item	ITT analysis			PP analysis
Item	Neosalpingostomy group (n=58)	Salpingectomy group (n=55)	P value	Neosalpingostomy group (n=50)	Salpingectomy group (n=55)	P value
Primary outcome
Live birth rate/n(%)	36 (62.07)	42 (76.36)	0.104^①	28 (56.00)	42 (76.36)	0.034^①
Secondary outcome
Mode of conception/n(%)
Spontaneous conception	16 (27.59)	0 (0)	NA	16 (32.00)	0 (0)	NA
IVF treatment	20 (34.48)	42 (76.36)	<0.001^①	12 (24.00)	42 (76.36)	<0.001^①
Gestational age at delivery/week	38.40 (37.60, 39.90)	38.40 (36.85, 38.90)	0.258^②	38.75 (37.80, 40.00)	38.40 (36.85, 38.90)	0.182^②
Biochemical pregnancy/n(%)	37(63.79)	42 (76.36)	0.163^①	29 (58.00)	42 (76.36)	0.054^①
Clinical miscarriage/n(%)	3(5.17)	5 (9.09)	0.417^①	3 (6.00)	5 (9.09)	0.548^①
Ectopic pregnancy/n(%)	12 (20.69)	1 (1.82)	<0.001^①	8 (16.00)	1 (1.82)	0.013^①
Time to first live birth/month
Spontaneous conception	23.00 (15.50, 43.50)	‒	NA	23.00 (15.50, 43.50)	‒	NA
IVF treatment	58.00 (34.00, 83.50)	19.25 (13.80, 27.50)	<0.001^②	55.20 (24.50, 81.00)	19.25 (13.80, 27.50)	<0.001^②

图3 累积活产率的Kaplan-Meier生存分析Note： A. Comparison of cumulative live birth rate between the neosalpingostomy group and salpingectomy group. The cumulative live birth rate was significantly higher in the salpingectomy group than that in the neosalpingostomy group (HR=2.18, 95%CI 1.37?3.45). B. Cumulative live birth rate through spontaneous conception in the neosalpingostomy group. It could be seen that the live birth rate through spontaneous conception rapidly increased within 3 years after neosalpingostomy, and slowed down considerably after 3 years. No live births through spontaneous conception were reported after 7 years.

Fig 3 Kaplan-Meier analysis on the cumulative live birth rate

图4 基于年龄分层的累积活产率Kaplan-Meier生存分析Note： A. The cumulative live birth rate of the salpingectomy group was significantly higher than that in the neosalpingostomy group among women younger than 35 years old (HR=2.25, 95%CI 1.39?3.66). B. Among women of 35 years old or older, the difference between the two groups did not reach statistical significance (HR=1.60, 95%CI 0.36?7.19).

Fig 4 Kaplan-Meier survival analysis of cumulative live birth rate based on age stratification

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输卵管整形与输卵管切除治疗双侧输卵管重度积水不孕女性长期妊娠结局的比较

Comparison of long-term pregnancy outcomes between neosalpingostomy and salpingectomy for infertile women with bilateral severe hydrosalpinx

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